MedDataX Logo

Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects

NCT ID: NCT01916850

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to evaluate the safety and tolerability of multiple oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive days) in healthy subjects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LX4211 Low Dose

400 mg of LX4211 administered once daily for 10 consecutive days

Group Type EXPERIMENTAL

LX4211 400 mg

Intervention Type DRUG

LX4211 High Dose

800 mg of LX4211 administered once daily for 10 consecutive days

Group Type EXPERIMENTAL

LX4211 800 mg

Intervention Type DRUG

Placebo

Identical placebo administered once daily for 10 consecutive days

Group Type PLACEBO_COMPARATOR

LX4211 Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LX4211 400 mg

Intervention Type DRUG

LX4211 800 mg

Intervention Type DRUG

LX4211 Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult subjects ≥ 18 to ≤ 55 years of age
* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
* Body mass index (BMI) ≥18 and ≤35 kg/sq m
* Willing and able to provide written informed consent

Exclusion Criteria

* Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 days of dosing
* Use of any investigational agent or study treatment within 30 days of dosing
* Use of any protein or antibody-based therapeutic agents within 3 months of Screening
* Prior exposure to LX4211
* Use of cigarettes or any tobacco products within 2 months prior to Screening and while participating in the study
* History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption
* History of any major surgery within 6 months of Screening
* History of any hypersensitivity to the inactive components of LX4211
* History of renal disease or significantly abnormal kidney function tests
* History of hepatic disease or significantly abnormal liver function tests
* History of any active infection within 14 days prior to Day 1
* History of alcohol or substance abuse within 2 years prior to Day 1
* Donation or loss of \>400 mL of blood or blood product within 3 months of dosing
* Positive urine glucose at Screening
* Positive urine screen for drugs of abuse, or urine test for alcohol at Screening or Day -1
* Inability or difficulty swallowing pills
* Unable or unwilling to communicate or cooperate with the Investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ikenna (Ike) Ogbaa, M.D.

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lexicon Investigational Site

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LX4211.110

Identifier Type: OTHER

Identifier Source: secondary_id

LX4211.1-110-NRM

Identifier Type: -

Identifier Source: org_study_id